Cleared Traditional

K061548 - STRYKER URETERAL ILLUMINATION SYSTEM IV (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K061548 · Stryker Corp. · Gastroenterology & Urology device
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Sep 2006
Decision
115d
Days
Class 2
Risk

K061548 is an FDA 510(k) clearance for the STRYKER URETERAL ILLUMINATION SYSTEM IV. Classified as Light, Catheter, Fiberoptic, Glass, Ureteral (product code FCS), Class II - Special Controls.

Submitted by Stryker Corp. (San Jose, US). The FDA issued a Cleared decision on September 28, 2006 after a review of 115 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4020 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Stryker Corp. devices

Submission Details

510(k) Number K061548 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 2006
Decision Date September 28, 2006
Days to Decision 115 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 130d · This submission: 115d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FCS Light, Catheter, Fiberoptic, Glass, Ureteral
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.4020
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.